Latest Criticism of the Food and Drug Administration Stories

LONDON, October 22, 2012 /PRNewswire/ -- Tracking Drugs@FDA and Orange Book Patent Data Provides Unrivaled Analysis of FDA Market Intelligence EvaluatePharma [http://www.evaluatepharma.com ], the premier source for life science sector analysis and consensus forecasts, today launched a new service enhancement, Tracking Drugs@FDA, which gives clients access to the entire universe of approved FDA drugs and the related FDA document library as well as FDA Orange Book patent...

Unique Device Identification System Will Provide FDA With a Critical Tool For Protecting Patients WASHINGTON, July 3, 2012 /PRNewswire-USNewswire/ -- The Food and Drug Administration (FDA) issued a proposed regulation today to establish a unique device identification (UDI) system for medical devices marketed in the U.S. A UDI system was mandated by Congress in 2007 but still is not in place. Legislation passed by Congress in June requires the FDA to implement the UDI system for high...

Bill Makes Some Improvements To Medical Device Oversight But Falls Short of Giving The FDA The Tools It Needs to Protect Patients WASHINGTON, June 25, 2012 /PRNewswire-USNewswire/ -- The Senate is expected to vote as early as today on a final version of the FDA Safety and Innovation Act, which was passed by the House last week. While the bill provides critical user fees to fund FDA oversight and makes some medical device safety improvements, it falls short of what is needed to...

House Bill Is Weaker Than Senate-Passed Version and Fails to Include Important Patient Safety Protections WASHINGTON, May 30, 2012 /PRNewswire-USNewswire/ -- The House is scheduled to vote on the Food and Drug Administration Reform Act today. The House bill is weaker than similar legislation passed by the Senate last week. Neither bill includes important provisions needed to protect patients from unsafe medical devices, according to Consumers Union, the policy and advocacy arm of...

Bill Makes Some Improvements to Medical Device Oversight But Important Patient Safety Protections Still Missing WASHINGTON, May 24, 2012 /PRNewswire-USNewswire/ -- The Senate approved the Food and Drug Administration Safety and Innovation Act today. While the legislation includes some improvements over current law, it leaves significant flaws with the FDA's current medical device oversight system in place, according to Consumers Union, the policy and advocacy arm of Consumer...

The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow. Led by second-year medical student Nicholas Downing and senior author Joseph S. Ross, M.D., assistant professor of internal medicine at Yale School of Medicine, the study will be...

Pharmaceutical drugs approved by the Food and Drug Administration (FDA) but later re-called from the market—such as the antidiabetic drug Avandia and pain-reliever Vioxx—were the impetus for an Institute of Medicine committee report released yesterday, recommending that the FDA take proactive steps to continue monitoring drugs' safety after initial approval and throughout their time on the market. One of the key recommendations made by the report, Ethical and Scientific Issues in...

Medical Device User Fee Bills Face Key Votes in Congress Next Week WASHINGTON, April 19, 2012 /PRNewswire-USNewswire/ -- Key House and Senate Committees will vote next week on legislation to reauthorize the statute governing medical devices at a time when the law has come under increasing criticism for failing to ensure devices are safe and effective. While the Senate legislation is stronger than the House version, neither bill includes critical reforms needed to protect patients...

The Food and Drug Administration (FDA) is considering making common drugs to treat diseases like diabetes and high cholesterol available to patients over the counter. The agency is seeking public comment until Friday on a way to make these medications more readily available. The goal is to make the drugs more available for those patients who have the diseases and do not take medicine. According to the Centers for Disease Control and Prevention (CDC), high blood pressure cost the U.S....

A weight-loss drug currently under a second review from the Food and Drug Administration (FDA) is causing concerns that it may be responsible for birth defects and heart problems, according to documents released by the agency on Friday. The drug, developed by Vivus, was rejected by the agency in 2010, largely because of those risks. A committee of outside advisers to the FDA will meet this week to reconsider whether the drug, called Qnexa, should move forward in the approval process,...